MAUDE Adverse Event Report: COVIDIEN LP VALLEYLAB; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	E0510
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
A laparoscopic monopolar cord was discovered to have burned through the connecting end where it plugs into a robotic monopolar scissor.The resident at bedside noted that it was hot to the touch, and upon inspection the end of the cord had a blackened burnt end.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10754989
• Report Number: 10754989
• Device Sequence Number: 16973589
• Product Code: GEI
• UDI-Device Identifier: 20884524001774
• UDI-Public: (01)20884524001774
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/07/2020
• Report Date (Section F): 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E0510
• Device Catalogue Number: E0510
• Device Lot Number: 1904164X
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/07/2020